# K955461: Transtracheal Catheter (Acc. Ravussin).

- Pathway: 510(k) (Traditional)
- Applicant: VBM Medizintechnik GmbH
- Decided: Mar 19, 1997 after 476 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- May 9, 2011 · Not classified · Z-2675-2011: Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants.
- May 9, 2011 · Not classified · Z-2676-2011: Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants.
- Jul 9, 2009 · Not classified · Z-2010-2009: user instructions not updated to correspond with product change

Source page: https://510kreport.com/device/K955461
Methodology: https://510kreport.com/methodology